New directions in pharmaceutical regulation and development will be explored in a new UK discussion forum set up under the aegis of the Department of Health's Ministerial Industry Strategy Group.
The Medicines and Healthcare products Regulatory Agency has put out a call for topics to be discussed by the forum and accompanying advisory panel jointly sponsored by the MHRA and the Association of the British Pharmaceutical Industry. The panel, which will include representatives of industry, regulators and the clinical academic community, as well as a lay member, is charged with identifying issues that could “challenge the current regulation of pharmaceuticals in the UK.”
The panel may either consider referring these topics to relevant pre-existing bodies or arrange a forum meeting for further discussion. The plan is that the forum should get together twice a year, with the first meeting scheduled for early 2007. The advisory panel will then draft any proposed action plans and, if appropriate, make recommendations for regulatory change to facilitate drug development.
In language reminiscent of the US Food and Drug Administration's Critical Path initiative, the MHRA said the ultimate goal of the forum was to help improve public health by “ensuring that early-stage pharmaceutical research can utilise the latest technology available to deliver medicines that are needed by patients and prescribers” and to make sure “regulatory requirements and guidelines take account of scientific developments, and industry has a clear understanding of the likely regulatory requirements in areas of scientific developments.”
The MHRA has posted a template for interested groups and members of the public to suggest topics for discussion on the agency's website at www.mhra.gov.uk. The closing date for proposals to be reviewed at the forum's inaugural meeting is 30 September 2006.
The MISG agreed to establish the forum and advisory panel in February this year as part of the long-term strategy for medicines in the UK first outlined in December 2004. The main planks of this strategy were to maintain and strengthen the UK's pharmaceutical industry within Europe and advance healthcare innovation within the National Health Service, while continuing to secure the provision of safe and effective medicines to patients.
The catalyst for the MISG, which also meets twice yearly, was the March 2001 report of the UK's Pharmaceutical Industry Competitiveness Task Force. This called for a new high-level group to take forward the relationship between government and the pharmaceutical industry at a strategic level. By Peter Mansell